During the spring and summer 2019, temporary shortages of various pharmaceuticals have evoked wide media coverage in Finland about pharmaceutical availability and drawn attention to the rising trend of shortage situations. The reasons behind this development are complex, ranging from global production problems and challenges in raw material availability to the fact that Finland is a small market where variety of licenced medicines is not as wide as for example in Middle Europe.
When a pharmaceutical product is temporarily available, what are the alternatives to secure patients’ care?
1. Is there another licenced pharmaceutical suitable for the patient?
“There is no universal solution, but each case is solved individually. Primary action is to secure patients’ medical care with another licenced pharmaceutical. But if there is no option to use another licenced product, the continuity of treatment can be secured with a special arrangement,” says Tiina Liipo, Product Manager, Special Licenced Medicines at Oriola.
2. An exception to the marketing authorisation or a special licence?
The Finnish Medicines Agency Fimea may allow an exception to the marketing authorisation which makes it possible to import product packages from another market even though the package information is in different language. Another option is to grant a special licence for a product that has no marketing authorisation in Finland.
“It is always the physician who makes the decision to apply for a special licence based on patient’s care needs. In addition to shortage situations, there are also other reasons why a licenced pharmaceutical cannot be used: the patient might be allergic to an ingredient or cannot swallow pills, or there is no licenced pharmaceutical that includes necessary medical substance,” says Terhi Heiliö, Special Licence and Marketing Coordinator at Oriola.
3. How to import a suitable medicine for the patient?
When a doctor has prescribed a patient a pharmaceutical that has no marketing authorisation in Finland, it is usually either a hospital pharmacy, a pharmacy or a veterinarian who contacts Oriola’s special licence service that helps to import both human and veterinary pharmaceuticals.
“We are continuously following the market to detect even small signals of potential needs for special licence products, since many shortage situations can be foreseen. This ensures that when the customer calls us, we can quickly start to map alternatives in close cooperation with pharmaceutical companies and officials in other countries,“ Liipo says.
If a suitable option to the customer need is found, Oriola’s special licence medicine team imports it. In the best-case scenario the pharmaceutical can be delivered to the patient the next day. This of course requires seamlessly working supply chain from transportation to customs. It is good to note that pharmaceutical supply chain requires special expertise since medicines might need e.g. special temperature control during transportation. To secure on-time and safe delivery, Oriola has employees in our logistics dedicated only to special licence medicines.